FDA Medical Device Recalls (openFDA)
Teleflex Medical: INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
- Recall number
- Z-2130-2017
- Recalling firm
- Teleflex Medical
- Product
- INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
- Status
- Terminated
- Initiated
- 2017-04-21
- Posted
- not on file
- Terminated
- 2020-01-27
- Reason
- not on file
- Root cause
- Labeling False and Misleading
- Action
- Consignees were notified via Urgent Medical Device Recall letter on April 21, 2017. The letter identified the affected product, problem and actions to be taken. They were instructed to discontinue use and quarantine any products with the affected catalog numbers and lot numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax it to the Attn: Customer Service or email to recalls@teleflex.com. A Recall Acknowledgment Form was enclosed to be completed and returned via fax even if they have no stock.
- Quantity
- 19,043 units in total
- Distribution
- Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.
- Lot, serial or model codes
- Product Code: PE103, Lot numbers: 02B1300991, 02B1402029, 02C1301654, 02E1201155, 02H1302224, 02K1100520, 02K1103125, 02K1200732, 02K1202185, 02L0701465, 02L0701959, 02L1201668, 02L1203112, 02M1201149, 74A1601005 & 74F1400876.74H1601152, 74J1601641, 74K1501590 & 74L1500555.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCD
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28